Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name gastrointestinal tubes with enteral specific connectors
510(k) Number K150679
Device Name EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01756
Applicant Contact Virginia Garcia
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01756
Correspondent Contact Virginia Garcia
Regulation Number876.5980
Classification Product Code
PIF  
Date Received03/17/2015
Decision Date 05/29/2015
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-